CompletedNot Applicable

Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases

France142 participantsStarted 2018-07-27

Plain-language summary

The investigators aim to measure the impact of a rehabilitation program in congenital cardiology in terms of health related quality of life. The orginality of the rehabilitation program consists in its design : initial hospitalizationfor a short period of time (5 days) at the rehabilitation center, followed by 11 weeks of rehabilitation at home under the supervision of a specialized sports trainer.

Who can participate

Age range

13 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient aged 13 to 25 years included * With a congenital heart diseases (CHD) as defined in the international CHD classification. * Recent (\< 3 months) cardio-pulmonary exercise test (CPET)with maximum oxygen uptake (VO2max) \<80% of theoretical values and/or first ventilatory anaerovic threshold (VAT) \<55% of VO2max. * Consent of the adult patient or the parents or legal guardians of the minor patient. * Beneficiary of the social security scheme. Exclusion Criteria: * Uncontrolled arrhythmia. * Cardiac surgery planned during the rehabilitation program. * Severe musculoskeletal disorders. * Severe intellectual disability that does not allow the quality of life questionnaire to be completed. * Pregnancy. * Patient who already underwent cardiac rehabilitation in the last 24 months. * All medical contraindications to perform a cardiorespiratory stress test. * Uncontrolled heart failure (NYHA IV) * Obesity (BMI \> 30)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quality of life score (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life.

Timeframe: follow up of patients over 12 months

Trial details

NCT IDNCT03690518

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-12

View on ClinicalTrials.gov More Heart Defects, Congenital trials